US12427132B2ActiveUtilityA1

Method of improving sleep

Assignee: VANDA PHARMACEUTICALS INCPriority: Feb 13, 2019Filed: Aug 16, 2022Granted: Sep 30, 2025
Est. expiryFeb 13, 2039(~12.6 yrs left)· nominal 20-yr term from priority
A61P 25/20A61K 31/343C12Q 2600/156C12Q 2600/106C12Q 1/6883A61P 43/00
89
PatentIndex Score
1
Cited by
15
References
10
Claims

Abstract

The invention provides methods of improving sleep in a patient having a variant of the cryptochrome circadian clock 1 (CRY1) genotype associated with a circadian rhythm sleep disorder (CRSD) Delayed Sleep Wake Phase Disorder (DSWPD).

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
       1. In a method of treating patients with tasimelteon, the improvement comprising:
 selecting a patient for said treatment who has delayed sleep wake phase disorder (DSWPD) and at least one copy of the rs112474322 allele. 
 
     
     
       2. The improvement of  claim 1 , wherein treating the patient includes administering tasimelteon to the patient once daily before bedtime. 
     
     
       3. The improvement of  claim 2 , wherein administering tasimelteon to the patient includes administering 20 mg of tasimelteon. 
     
     
       4. The improvement of  claim 1 , wherein treating the patient with tasimelteon improves at least one sleep parameter selected from a group consisting of: latency to persistent sleep (LPS); sleep efficiency (%) during the first, second, and/or final thirds of the night; rapid eye movement (REM) sleep duration; total sleep time (TST), including during the first two-thirds of the night; and wake after persistent sleep (WASO). 
     
     
       5. A method for treating a patient exhibiting one or more symptoms of delayed sleep wake phase disorder (DSWPD), which comprises:
 identifying that said patient has at least one copy of the rs112474322 allele; and 
 administering an amount of tasimelteon to said patient effective to treat said one or more symptoms. 
 
     
     
       6. The method of  claim 5 , wherein the amount of tasimelteon is 20 mg. 
     
     
       7. The method of  claim 5 , wherein treating said one or more symptoms includes improving at least one sleep parameter selected from a group consisting of: latency to persistent sleep (LPS); sleep efficiency (%) during the first, second, and/or final thirds of the night; rapid eye movement (REM) sleep duration; total sleep time (TST), including during the first two-thirds of the night; and wake after persistent sleep (WASO). 
     
     
       8. A method for improving one or more sleep parameters in an individual suffering from delayed sleep wake phase disorder (DSWPD), the method comprising:
 identifying that said individual has at least one copy of the rs112474322 allele; and 
 administering to said individual daily, at a time proximately before the individual's established bedtime, an amount of tasimelteon effective to improve one or more sleep parameters in said individual. 
 
     
     
       9. The method of  claim 8 , wherein the amount of tasimelteon is 20 mg. 
     
     
       10. The method of  claim 8 , wherein the one or more sleep parameters is selected from a group consisting of: latency to persistent sleep (LPS); sleep efficiency (%) during the first, second, and/or final thirds of the night; rapid eye movement (REM) sleep duration; total sleep time (TST), including during the first two-thirds of the night; and wake after persistent sleep (WASO).

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